Our lead projects
To move closer to our vision of a world free of pain, we are currently pursuing a range of programmes across different modalities, targets and mechanisms of action. Here are some selected highlights from our development pipeline.
Qutenza™ Life Cycle Management
Qutenza™ is a patch containing prescription-strength capsaicin. In Europe, it is approved for the treatment of peripheral neuropathic pain. In the US, it is approved for the treatment of neuropathic pain associated with post-herpetic neuralgia, and in 2020 it also received approval for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.
Our life-cycle management efforts focus on making Qutenza™ more widely available by expanding the label further, particularly in the United States. Specifically, we have started a pivotal Phase III study in post-surgical neuropathic pain. We are also pursuing selected further exploratory activities in other indications with external partners.
Phase III trial AV001 with QUTENZA®: Recruitment completed
Tegacorat (GRM-01)
Glucocorticoids, such as prednisolone, are known to be highly effective anti-inflammatory drugs. However, they come with several significant side effects, including reduced bone formation that may lead to osteoporosis, as well as increased glucose levels, which raises the risk of diabetes. These side effects are a strong limitation for the long-term use of glucocorticoids, despite their efficacy. With our GRM programme, we are pursuing the development of clinical candidates for oral treatment with broad anti- inflammatory efficacy and the potential of significantly reduced side effects when compared to available glucocorticoid-based therapies.
A clinical Phase I trial for Tegacorat, the most advanced compound within our GRM programme, involved 88 healthy participants and primarily aimed to characterise its safety and tolerability profile, while also confirming the pharmacokinetic characteristics of the compound. Biomarker data demonstrated the compound’s potential to offer a therapy that combines high efficacy with a favourable safety profile.
Tegacorat will be investigated in a Phase II trial in 4 to >7-year-old boys with Duchenne Muscular Dystrophy who have not previously taken steroids. The trial will commence in 2026 with centers in US & Europe.
Nociceptin/Orphanin FQ receptor Peptide agonist (NOP)
Although several different treatment options are available, many patients with neuropathic pain still suffer from treatment non-response or insufficient pain relief. With our NOP programme, we are pursuing the development of a selective, peripherally-restricted oral treatment with a unique mechanism of action for chronic pain that offers a more favourable safety profile than current therapies. This programme is based on our many years of intense and ground-breaking research in the field of NOP receptors, and opens up a unique opportunity for a transformative first-in-class treatment.
First participants enrolled in first-in-human Phase I clinical trial with nociceptin (NOP) receptor agonist
Read more in our press release
NaV – Creating the next generation of non-opioid pain medicines
One of Grünenthal’s most promising early research areas is our voltage-gated sodium channels (NaV) programme, where we are striving to create the next generation of non-opioid pain medicines. NaV channels can carry sodium ions into cells, resulting in an excitatory signal. If a channel's activity is modified so it can no longer carry sodium ions, it will also no longer be able to evoke excitatory signals. Of the family of nine NaV channels, we are particularly interested in those expressed in dorsal root ganglion neurones.
These specific channels play roles in triggering excitatory signals in nociceptive neurones which are felt as pain by the human brain. As well as recognising their key role in pain signalling, genetic and some clinical validation make them promising human pain targets. Manipulating these NaV channels in a way that suppresses or prevents their excitatory signalling could provide a significant analgesic effect across a range of chronic and acute pain conditions.
Our lead candidate, a NaV 1.8 inhibitor, has entered clinical development in Q1 2026.
Read press release